First Objective: Is the percentage of subjects that dynamic hyperinflate during activities of daily living larger in patients with mild COPD than in healthy controls?Second Objective(s): Will dynamic hyperinflation induced by activities of daily…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
For the first objective, the main study parameter is the percentage of subjects
that show dynamic hyperinflation during ADL.
For the second objective, the main study parameter is the difference in dynamic
hyperinflation during ADL between baseline and after two years of follow-up.
Secondary outcome
Measured during ADL:
Ventilatory parameters: ventilation (Ve), breathing reserve (BR), Ve/maximal
ventilatory capacity (MVC), ventilatory equivalent for CO2 (Ve/VCO2), partial
pressure of end-tidal CO2 (PetCO2), breathing frequency (BF).
Operational lung volumes: inspiratory reserve volume (IRV), tidal volume (Vt)
Cardiovascular parameters: heart rate (HR), HR reserve, O2-pulse, blood
pressure
Other: oxygen consumption (VO2), dyspnea, ADL-time, gas exchange
Background summary
Most studies and also interventions focus on the more severe stages of chronic
obstructive pulmonary disease (COPD). However, it has been shown that mild COPD
is already related with significant health-related problems, including
increased mortality, enhanced FEV1 decline, decreased muscle strength and
health-related quality of life. Compared to controls, patients with mild COPD
showed exercise intolerance and experienced more dyspnea during exercise. The
occurrence of air trapping (dynamic hyperinflation, DH) was suggested to cause
the exercise limitation. Because of the significant health-related problems in
mild COPD we hypothesize that these patients also experience difficulties
during activities of daily living (ADL). Patients with mild COPD showed DH
during maximal incremental exercise and therefore we hypothesize that DH will
also occur during ADL in those mild COPD patients. In a pilot study
(NL37406.091.11; 2011/296) of 20 patients with mild COPD a significant
percentage seems to hyperinflate during ADL.
In addition, studies investigating the behavior of physiological impairments
and complaints during ADL over time have not been performed. We expect DH will
be increased in COPD patients after 2 years, compared with no changes for
controls.
Study objective
First Objective: Is the percentage of subjects that dynamic hyperinflate during
activities of daily living larger in patients with mild COPD than in healthy
controls?
Second Objective(s): Will dynamic hyperinflation induced by activities of daily
living increase after 2 years of follow-up in patients with mild COPD and is
this change in dynamic hyperinflation different compared to the change in
healthy controls?
Study design
This observational study is set as a cross-sectional study (survey) for the
first objective. The second part of the study (second objective) is a
prospective follow-up.
Study burden and risks
The procedures we will use for measurements of lung function and exercise
capacity are part of the usual diagnostic procedure of COPD patients. The
measurements during ADL carry no risks.
During this study a lot of tests will be performed in both patients with COPD
and control subjects. For both groups this will be a chance to obtain objective
insights in their health condition, which can be seen as a benefit for them. In
addition general practitioners of the patients will receive a report about
individual patient test results, so he can offer feedback and a possible
treatment advice to improve health condition of the patient.
Nijmeegsebaan 31
Groesbeek 6561KE
NL
Nijmeegsebaan 31
Groesbeek 6561KE
NL
Listed location countries
Age
Inclusion criteria
Patients: Clinically stable COPD patients with GOLD I (=mild COPD, a FEV1/VC ratio (forced expiratory volume in one second divided by the vital capacity) < 0,7 and FEV1 >= 80% of predicted)and >= 18 years old.
Controls: Subjects with normal lung function and with similar ages and gender distribution as the patients with COPD
Exclusion criteria
Patients: patients with long term oxygen therapy at home, with co-existing lung disease other than COPD (including asthma), with restrictive lung function, with other exercise-limiting disorders than COPD like cardiac or neuromuscular disease, or patients using β-blockers are excluded from the study.
Controls: subjects with abnormal lung function or history of lung disease or with exercise-limiting disorders like cardiac or neuromuscular disease are excluded from the study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL42423.091.12 |